Skip to content

The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion

A Retrospective and Prospective Cohort Study to Investigate the Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05490901
Acronym
EX_CATH
Enrollment
400
Registered
2022-08-08
Start date
2020-03-17
Completion date
2029-06-30
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pulmonary Thromboembolism (Disorder), Heart Failure With Preserved Ejection Fraction

Keywords

Exercise hemodynamic test, Heart failure with preserved ejection fraction, Cardiac catheterization

Brief summary

To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Detailed description

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. However, in practice, it's difficult to recognize early stage of HFpEF by resting hemodynamic study and echocardiography because the patients mainly complaint of dyspnea only during exercise but not resting condition. Accordingly, exercise stress test will be helpful to provide more information on pathophysiology, diagnosis, and severity in various cardiovascular diseases such as HFpEF, valvular heart disease, and chronic thromboembolic pulmonary hypertension. Thus, the broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance. Specifically, this study will compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Interventions

DIAGNOSTIC_TESTExercise hemodynamic test

Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject must be at least 19 years of age. * Patients with dyspnea on exertion * Written informed consent of participating subjects after being fully briefed (for prospective analysis)

Exclusion criteria

* Patients with incomplete hemodynamic data at rest or exercise * Advanced tumor disease or other diseases with a short life expectancy * Uncontrolled systemic arterial hypertension ( \> 160/100 mmHg at rest) * FEV1\<50% predicted * TLC\<60% predicted

Design outcomes

Primary

MeasureTime frameDescription
Proportion of exercise induced pulmonary artery wedge pressure >25 mmHgduring the procedureNumber of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP

Secondary

MeasureTime frameDescription
The change of right ventricular systolic pressure (RVSP) between at rest and peak exercisebetween at rest and peak exerciseThe change of RVSP between at rest and peak exercise
Proportion of exercise induced pulmonary hypertension > 30 mmHgduring the procedureNumber of Participants with Diagnosis of pulmonary hypertension based on mean pulmonary pressure at peak exercise
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiographyduring the procedureCorrelation between peripheral venous pressure and right atrial pressure assumed by echocardiography
Ventilatory mechanicsduring the procedureratio of minute ventilation to carbon dioxide production (VE/VCO2)
Aerobic capacityduring the procedurepeak oxygen consumption (VO2)
coronary flow reserveduring the procedureinvasively measured coronary flow reserve
index of microcirculatory resistanceduring the procedureinvasively measured index of microcirculatory resistance
Lactate level at peak exerciseduring the procedureSerum lactate level at peak exercise
LA stiffnessduring the procedureLA stiffness measured by LA strain/E/e' using Transthoracic echocardiography
change of E/e' between at rest and peak exercisebetween at rest and peak exerciseThe change of E/e' between at rest and peak exercise
Rates of rehospitalization due to heart failure5 years follow-upRehospitalization due to heart failure
Rates of all-cause death5 years follow-upFollow-up death
change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercisebetween at rest and peak exerciseThe change of TAPSE between at rest and peak exercise
change of S' between at rest and peak exercisebetween at rest and peak exerciseThe change of S' between at rest and peak exercise

Countries

South Korea

Contacts

Primary ContactJeong Hoon Yang, MD
jhysmc@gmail.com82-2-3410-3419
Backup ContactKi Hong Choi, MD
cardiokh@gmail.com82-2-3410-6653

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026